Blank CIOMS 1 Form (meb_pv_doc

CIOMS FORM

SUSPECT ADVERSE REACTION REPORT

I. REACTION INFORMATION

1. PATIENT INITIALS	1a. COUNTRY	2. DATE OF BIRTH			2a. AGE	3. SEX	4-6 REACTION ONSET			8-12 CHECK ALL
(first, last)		Day	Month	Year	Years		Day	Month	Year	APPROPRIATE TO ADVERSE REACTION
7 + 13 DESCRIBE REACTION(S) (including relevant tests/lab data) Serious Unexpected										¨ PATIENT DIED ¨ INVOLVED OR PROLONGED INPATIENT HOSPITALISATION ¨ INVOLVED PERSISTENT OR SIGNIFICANT DISABILITY OR INCAPACITY ¨ LIFE THREATENING

II. SUSPECT DRUG(S) INFORMATION

14. SUSPECT DRUG(S) (include generic name)		20. DID REACTION ABATE AFTER STOPPING DRUG? ¨ YES ¨ NO ¨ NA
15. DAILY DOSE(S)	16. ROUTE(S) OF ADMINISTRATION	21. DID REACTION REAPPEAR AFTER REINTRO-
17. INDICATION(S) FOR USE		DUCTION? ¨ YES ¨ NO ¨ NA
18. THERAPY DATES (from/to)	19. THERAPY DURATION

III. CONCOMITANT DRUG(S) AND HISTORY

22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to treat reaction)
Drug (substance) Begindate - Enddate

23. OTHER RELEVANT HISTORY (e.g. diagnoses, allergies, pregnancy with last menstrual period, etc.)

IV. MANUFACTURER INFORMATION

24a. NAME AND ADDRESS OF MANUFACTURER		COMMENTS
ORIGINAL REPORT NO.	24b. MFR CONTROL NO.	Reporting source:
24c. DATE RECEIVED BY MANUFACTURER	24d. REPORT SOURCE ¨ STUDY ¨ LITERATURE ¨ HEALTH PROFESSIONAL
DATE OF THIS REPORT	25a. REPORT TYPE ¨ INITIAL ¨ FOLLOW-UP